Siemens CLINITEK Status+ Operator'S Manual Download Page 135

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CLINITEK Analyzer Operator’s Guide

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Speci

fications

Appendix D: Specifications

This appendix contains the analyzer specifications and tables of results.

Analyzer Specifications

This appendix summarizes the design specifications for the
CLINITEK analyzer and provides summary tables of test results
from the CLIA waiver and the physician office studies.

Summary of Contents for CLINITEK Status+

Page 1: ...nd Settings punysh00 Desktop Version 2 2 Source 0_title_legal fm It was last modified August 25 2011 3 56 pm It was printed August 25 2011 P r e l i m i n a r y CLINITEK Status Analyzer Operator s Guide 10379682 134798 Rev B 2011 06 ...

Page 2: ...nd Cidex are trademarks of Johnson Johnson Theracide is a trademark of Lafayette Pharmaceuticals Inc Amphyl is a trademark of Linden Corporation Kimwipes is a trademark of Kimberly Clark Origin UK The information in this operator s guide was correct at the time of printing However Siemens Healthcare Diagnostics continues to improve products and reserves the right to change specifications equipment...

Page 3: ...est Results 33 Completing the Urinalysis Strip Quick Test 34 Performing an hCG Cassette Quick Test 35 Preparing a Cassette Quick Test 35 Running a Cassette Quick Test 36 Viewing the Cassette Quick Test Results 37 Printing the Cassette Quick Test Results 37 Completing the Cassette Quick Test 38 Performing a Urinalysis Strip Full Test 38 Entering Operator and Patient Information 38 Preparing a Urina...

Page 4: ...ing the Outside of the Analyzer 62 Changing the Batteries 63 5 Troubleshooting Error Messages 65 Errors That Require Correction 65 Advisory Error Messages 66 Results Alert 66 Errors and Advisory Messages 66 Troubleshooting the Analyzer Operation 74 Calling for Assistance 76 Technical Support 76 Customer Support 77 Problem List 77 6 File Management Recalling the Patient Test Results 80 Sending All ...

Page 5: ...inter Settings 119 Changing the Quality Control Settings 121 Restoring the Default Settings 121 Updating the Analyzer Software 122 Running Diagnostics 126 Viewing the System Information 126 Viewing and Printing the System Configuration Settings 127 Appendix A Safety Information Protecting Yourself from Biohazards 129 Recognizing Sources of Contamination 129 Preventing Contamination 129 References ...

Page 6: ...fications 137 Electromagnetic Compatibility EMC 137 Tables of Results 137 English Units Conventional 138 English Units International SI 143 English Nordic Units Nordic Plus System 148 Appendix E Symbols Analyzer and Labeling Symbols 153 Analyzer and Packaging Symbols 153 Analyzer Symbols 154 Display Icons 156 Appendix F Glossary Hardware Terms 159 Software Terms 160 Acronyms 165 Index 167 ...

Page 7: ... to Creatinine Ratio Albumin to Creatinine Ratio Specific Gravity Urobilinogen and human Chorionic Gonadotropin hCG These measurements are used to assist diagnosis in the following areas Kidney function Urinary tract infections Metabolic disorders such as diabetes mellitus Liver function Pregnancy Tests perfomed using the CLINITEK Status analyzer are intended for in vitro diagnostic use only The C...

Page 8: ...ultistix PRO urinalysis strips are for in vitro diagnostic use They have been determined to be nonhazardous under the guidelines issued by OSHA in 29 CFR 1910 1200 d Getting Started This section provides information about how to unpack and install your CLINITEK Status analyzer Unpacking the Clinitek Status Analyzer The CLINITEK Status analyzer is delivered in 1 carton To unpack your CLINITEK Statu...

Page 9: ...at has 4 or fewer test pads such as Uristix 4 reagent strips use a short test table insert You need to order the short test table insert separately from the analyzer see Appendix C Orderable Supplies Paper roll Note You also can print on label stock For information about how to order label rolls see Appendix C Orderable Supplies CAUTION Do not touch the white calibration bar on the test table Dama...

Page 10: ...ard Figure 1 1 Clinitek Status Analyzer Components Assembling the Clinitek Status Analyzer After you unpack the analyzer components you can assemble and connect them To assemble the Clinitek Status Analyzer components perform the following steps 1 Clinitek Status Analyzer 2 Power supply adaptor and AC power cord Figure shows US version 3 Test table with calibration bar 4 Test table insert 5 Paper ...

Page 11: ...yzer see Figure 1 2 Figure 1 2 Assembling the Clinitek Status Analyzer Connect the other end of the power cord into an AC electrical wall outlet CAUTION The best temperature for using the analyzer is between 22 and 26 C 72 and 79 F Do not place the analyzer outdoors or near windows ovens hot plates or radiators 1 Serial port 2 Power cord CAUTION Use only the power supply adapter included with the ...

Page 12: ...table and test table insert perform the following steps 1 Insert the test table into the analyzer by holding it by the end opposite the white calibration bar and with the white bar facing up 2 Push the test table into the analyzer pushing it in just over halfway 3 Place the test table insert into the test table see Figure 1 3 CAUTION Do not use batteries in the analyzer if you attach the analyzer ...

Page 13: ... The Test Table and Test Table Insert Connecting the Analyzer to a Computer To connect the analyzer to a computer perform the following steps 1 Purchase a 9 pin null modem serial cable from your local technical support provider or distributor See Appendix B Support Information 2 Connect the serial cable to the serial port located on the back of the analyzer 3 Connect the other end of the serial ca...

Page 14: ...s see the CLINITEK Status Connect System Operator s Guide Loading the Printer Paper The analyzer uses ordinary thermal paper as provided or label stock For more information about ordering supplies see Appendix C Orderable Supplies To load the printer paper or label roll perform the following steps 1 With the back of the analyzer facing you open the printer cover by pulling up on the tab 2 Open the...

Page 15: ...closed position see Figure 1 4 8 Close the paper roll and printer covers by clicking them into position Note By default the analyzer automatically prints the test results To disable the automatic print function see Section 7 System Configuration Changing the System Settings page 107 Figure 1 4 Printer Paper Compartment 1 Paper holding arm 2 Printer paper ...

Page 16: ...lyzer If this is the first time you powered on the analyzer the Start Up Wizard displays and prompts you to select a region 2 Select a region Note If your region does not display in the list select Other The Authorization Code screen displays 3 For the start up code enter 2664 Note If you enter an incorrect start up code the Incorrect Authorization Code error message displays Select No to return t...

Page 17: ...e analyzer powers off If a strip or cassette is still on the test table the analyzer pushes out the test table and powers off The test table remains out To pull the test table into the analyzer power on the analyzer remove the strip or cassette on the test table and then power off the analyzer CAUTION Do not push the test table fully into the analyzer The test table might become jammed and prevent...

Page 18: ...er Connections and power Memory card slot Display You interact with the CLINITEK Status analyzer through an integrated touch screen display The touch screen displays messages options and requests for information You respond by selecting a button or an area on the screen see Figure 1 5 CAUTION Do not use anything hard or pointed on the touch screen It might damage the screen ...

Page 19: ...ce the strips or the cassette on the test table insert Note If you use a urinalysis strip that has 4 or fewer test pads such as Uristix 4 reagent strips use a short test table insert You need to order the short test table insert separately from the analyzer see Appendix C Orderable Supplies 2 The analyzer pulls in the test table partially for calibration and then pulls in the test table completely...

Page 20: ...sults Connections and Power Connect the analyzer into an electrical outlet to use on a benchtop or use batteries so you can freely move the analyzer from one testing site to another Memory Card Slot The memory stores the analyzer software operating parameters settings you select up to 950 patient test results and 200 authorized operators The information is stored in the memory whether the analyzer...

Page 21: ...ce consists of a touch screen with an onscreen alphanumeric keyboard Touch Screen Use the Select Ready screen to configure the analyzer run tests recall results and navigate to any point in the software see Figure 1 7 The Select Ready screen contains the following elements Title bar Contains the current screen name date and time Selection area Includes Instrument Set Up Recall Results Cassette Tes...

Page 22: ...uction Note Depending on the screen that displays when the analyzer is idle for a period of time the analyzer returns to the Select Ready screen Figure 1 7 Select Ready Screen 1 Title bar 2 Recall Results 3 Strip Test 4 Cassette Test 5 Instrument Set Up ...

Page 23: ...tes that the analyzer is powered by batteries A screen also can display buttons instructions alert messages and error messages Figure 1 8 Screen Elements Tap the screen lightly in a selection area or button to select an option or button or to navigate in a list of items 1 Help 2 Selection Area 3 Button 4 Instructions 5 Icon CAUTION Do not use anything hard or pointed on the touch screen It might d...

Page 24: ...election For example Sound on Sound off and Key clicks only are instrument setup options To change your selection select an option button with an unfilled circle The newly selected circle round option button is highlighted In the example the Sound on option is selected Selection Area Selection areas enclosed in boxes on the screen indicate functions that you can select Select a boxed area to activ...

Page 25: ...isplay at the bottom of the screens which include Select and Done To navigate the screens the analyzer displays left and right arrow buttons To move to the previous screen select Previous left arrow To move to the next screen select Next right arrow Screen Element Example Description ...

Page 26: ...t to scroll When an arrow is dimmed you are viewing the first item or last item in the list and cannot scroll beyond that page Note When an item in a list displays a highlighted bar you can select that item Double Arrows When double arrows display on the screen you select these arrows to move to the top or bottom of the page When a double arrow is highlighted you can use it to scroll When a double...

Page 27: ...y If you run a CLINITEK Status analyzer with a CLINITEK Status connector you can connect a handheld bar code reader to the analyzer and scan information for some values You also can connect a keyboard to the analyzer where the analyzer recognizes only the keyboard input equivalent to the alphabetic and numeric characters on the onscreen keyboards For example to enter a name number or birth date se...

Page 28: ...28 CLINITEK Status Analyzer Operator s Guide ...

Page 29: ...formation from a bar code reader Note You cannot cancel a test before the analyzer finishes the test View and print the test results that display on the screen Performing a Urinalysis Strip Quick Test When you place a urinalysis strip on the test table the analyzer calibrates and starts to perform the analysis Perform the following procedure to test a strip Preparing a Urinalysis Strip Quick Test ...

Page 30: ...Ready screen select Strip Test 2 If you enabled lot information with Instrument Set Up enter the strip lot number and expiration date as follows Otherwise go to step 3 To use the last strip number and begin the test select Use Last Lot To enter new strip data select Enter new lot and expiration Enter the strip lot number and select Enter Use the arrow keys to enter the strip expiration date and se...

Page 31: ...e the strip from the urine 4 Drag the edge of the strip against the side of the sample container as you remove it 5 Blot the edge of the strip on a paper towel to remove the excess urine 6 Place the reagent strip in the test table channel with the test pads facing up 7 Slide or push the strip to the end of the channel Do not touch the pads on the strip After the 8 second countdown ends the analyze...

Page 32: ...n the Results screen To view additional pages of the urinalysis strip Quick Test results and the sample interference notes perform the following steps 1 Select More to view the remaining test results If you use reagent strips with an ID band you can view sample interference notes for this test 2 Select Notes to view the sample interference notes if the analyzer generated them for the test The Inte...

Page 33: ...vated GLU may cause falsely lowered LEU results Visibly bloody urine may cause falsely elevated PRO results High SG may cause falsely lowered LEU results High pH may cause falsely elevated PRO results Printing the Urinalysis Strip Quick Test Results Print the urinalysis strip Quick Test results manually or automatically or send the results to a computer To print the urinalysis strip Quick Test res...

Page 34: ...ick Test Complete the Quick Test for one strip or continue testing one strip at a time until you finish testing all the strips you want to analyze To complete the urinalysis strip Quick Test perform the following steps 1 Remove the used urinalysis strip from the test table and dispose of it according to your standard laboratory procedures 2 Wipe the table insert if necessary see Section 4 Maintena...

Page 35: ...on date To use the last cassette number and begin the test select Use Last Lot To enter new cassette data select Enter new lot and expiration Enter the cassette lot number and select Enter Use the arrow keys to enter the cassette expiration date and select Enter 3 On the Test Type screen select Clinitest hCG cassette The Prepare Test screen displays Note To display the cassette testing steps on th...

Page 36: ... sample to the line marked on the pipette approximately 0 2 mL 3 Add the entire contents of the pipette into the sample well of the test cassette After the 8 second countdown ends the analyzer pulls in the test table and cassette and then calibrates Note Each time you run a test the analyzer calibrates After the calibration finishes the analyzer starts analyzing the cassette and the Analyzing scre...

Page 37: ...nsert For instructions on how to set up the analyzer so that you can print the results automatically or send the results to a computer see Section 7 System Configuration Changing the Connectivity Settings page 110 Viewing the Cassette Quick Test Results The test results display on the Results screen Select Done to return to the main Results screen Printing the Cassette Quick Test Results Print the...

Page 38: ... Then the display returns to the Select Ready screen Performing a Urinalysis Strip Full Test With a urinalysis strip full test you can enter an Operator Name Patient Name and Patient ID When you place the strip on the test table the analyzer calibrates and starts to perform the analysis Perform the following procedures to test a strip Entering Operator and Patient Information Enter or select an op...

Page 39: ...To enter a previous patient a Select Recall Patient b Scroll through the patient name list The most recently performed test displays at the top of the list c Highlight the patient name and select Select Note The patient name list displays up to 200 patients in chronological order When the list reaches 200 patients the analyzer deletes the oldest name from the list You cannot retrieve the deleted n...

Page 40: ...follows otherwise go to step 2 To use the last strip number and begin the test select Use Last Lot To enter new strip data select Enter new lot and expiration Enter the strip lot number and select Enter Use the arrow keys to enter the strip expiration date and select Enter 2 Make sure the reagent strip holder faces upward in the test table insert 3 Have the urinalysis strip and paper towel ready R...

Page 41: ...ip in the test table channel with the test pads facing up 7 Slide or push the strip to the end of the channel Do not touch the pads on the strip After the 8 second countdown ends the analyzer pulls in the test table and strip and then calibrates Note Each time you run a test the analyzer calibrates After the calibration finishes the analyzer starts analyzing the strip and the Analyzing screen disp...

Page 42: ...ays the first page of the test results on the Results screen The results display on the screen for 2 minutes Then the display returns to the Select Ready screen The test table and strip move out of the analyzer Note If you set up the analyzer to print the test results automatically the Printing screen displays until the printout finishes If you set up the analyzer with a connection to a PC the ana...

Page 43: ...st results the analyzer generates notes for this patient test 3 Select the up and down arrows to scroll through the notes 4 Select Done to return to the main Results screen Printing the Urinalysis Strip Full Test Results Print the urinalysis strip Full Test results manually or automatically or send the results to a computer To print the urinalysis strip Full Test results manually select Print to p...

Page 44: ...ion 4 Maintenance Weekly Cleaning of the Test Table and Test Table Insert page 57 3 Report the results to a laboratory supervisor or physician 4 Select Done to complete the test and return to the Select Ready screen 5 Select Done to return the Strip Test Prepare screen You are ready to start the next test If you completed your testing select Back to return to the Select screen Performing an hCG Ca...

Page 45: ...u can scan the operator name from a bar coded label using the handheld bar code reader 3 On the Patient Information screen enter the patient information To look up a previous patient select Recall Patient Scroll through the paitent name list The most recently performed test displays at the top of the list Highlight the patient name and select Select Note The patient name list displays up to 200 pa...

Page 46: ...ion b Enter the cassette lot number and select Enter c Use the arrow keys to enter the cassette expiration date and select Enter 3 On the Test Type screen select Clinitest hCG cassette The Prepare Test screen displays Note To display the cassette testing steps on the screen select Help 4 Position the test table insert in the test table for a cassette test 5 Remove the test cassette from the foil p...

Page 47: ...ates After the calibration finishes the analyzer starts analyzing the cassette and the Analyzing screen displays The analyzer displays either of the following screens Analyzing If the cassette is still being analyzed Results If analyzing the cassette has been completed A timer counts down the time remaining in the cassette analysis process After the countdown ends the analyzer displays the test re...

Page 48: ...est results see the Clinitest hCG cassette test instructions for use insert For instructions on how to set up the analyzer so that you can print the results automatically or send the results to a computer see Section 7 System Configuration Changing the Connectivity Settings page 110 Viewing the Cassette Full Test Results The test results display on the Results screen Select Done to return to the m...

Page 49: ...e from the test table and dispose of it according to your standard laboratory procedures 2 Wipe the table insert if necessary see Section 4 Maintenance Weekly Cleaning of the Test Table and Test Table Insert page 57 3 Report the results to a laboratory supervisor or physician 4 Select Done to complete the test 5 Select Back to return to the Select Ready screen Note Keep the calibration bar clean t...

Page 50: ...50 CLINITEK Status Analyzer Operator s Guide Operations ...

Page 51: ...stitute of Standards and Technology NIST traceable calibrators Siemens can show traceability to NIST Note Keep the calibration bar clean to ensure accurate results For details about cleaning the calibration bar see the next section on Cleaning the White Calibration Bar Cleaning the White Calibration Bar For the CLINITEK Status analyzer to perform as intended and provide reliable test results the w...

Page 52: ...steps a Place the test table into the analyzer by holding the table at the end opposite the white calibration bar with the white calibration bar facing upward b Push the test table firmly but slowly just over halfway into the analyzer c Place the test table insert CAUTION Do not touch the calibration bar while you examine it or after you clean it Your fingerprints or lint on the bar could cause un...

Page 53: ...g correctly and that the analyzer is accurately reading them QC also helps detect errors that result from user techniques QC should be performed in accordance with local state and federal guidelines This chapter provides only a general overview of quality control testing To run quality control follow the instructions in the quality control instructions for use product insert If you run a CLINITEK ...

Page 54: ...ts to the QC manufacturer s acceptable results list If the QC results are not acceptable do not test the patient samples until you solve the problem Repeat QC tests until you have acceptable results For expected values for each analyte see the quality control instructions for use product insert hCG Cassette Quality Control Testing Each test includes two procedural controls which indicate that suff...

Page 55: ...uct instructions for use insert try any of the following corrective actions Use a fresh strip out of a bottle or a fresh cassette out of a package and repeat the QC test Use a fresh bottle of strips or fresh package of hCG cassettes to repeat the quality control procedure Use a fresh control solution and repeat the quality control procedure If you use lyophilized controls prepare the control solut...

Page 56: ...56 CLINITEK Status Analyzer Operator s Guide Calibration QC ...

Page 57: ...nd Test Table Insert Clean the test table and test table insert on a weekly basis or more frequently if necessary to ensure test result accuracy and prevent contamination and bacterial growth To clean the test table and test table insert perform the following steps 1 Remove the test table by pulling it slowly out of the analyzer 2 Lift the table insert to remove it from the test table 3 Drain the ...

Page 58: ...sert Cleaning the White Calibration Bar For the CLINITEK Status analyzer to perform as intended and to provide reliable test results the white calibration bar on the test table needs to be clean and not discolored CAUTION Do not to scratch the white calibration bar Marks and stains could cause inaccurate test results especially for hCG tests Severe marks can cause errors CAUTION Do not touch the c...

Page 59: ...ean and unmarked perform the following steps a Re insert the test table into the analyzer by holding the table at the end opposite the white calibration bar with the white calibration bar facing upward b Push the test table firmly but slowly just over halfway into the analyzer c Insert the test table insert BIOHAZARD Wear personal protective equipment Use universal precautions For recommended prec...

Page 60: ...esentative d Insert the test table and table insert as described in step 5 Disinfecting the Test Table and Table Insert Disinfect the test table and the test table insert as necessary following your lab guidelines Use a recommended disinfection solution for the following reasons Prevent contamination Prevent bacterial growth Avoid damage to the test table and insert CAUTION Do not scratch the whit...

Page 61: ... as full strength 2 Remove the table insert from the test table 3 Remove the test table by pulling it slowly out of the analyzer 4 Drain the drip tray if necessary 5 Place the table insert and test table into the solution with the white calibration bar on the test table above the liquid level 6 Soak the test table and the table insert for a minimum of 2 minutes and a maximum of 10 minutes CAUTION ...

Page 62: ...the analyzer by pressing the on off button for 2 seconds 2 Wipe the outside including the display with a damp not wet cloth and a mild detergent CAUTION Rinse away all the solution residue as any remaining solution might affect the reagent pad chemistries BIOHAZARD Wear personal protective equipment Use universal precautions For recommended precautions when you work with biohazardous materials see...

Page 63: ...esult printout might be lighter when you use batteries to power the analyzer If you do not use the analyzer in 3 minutes when it is battery powered it automatically powers off When you power the analyzer by batteries a battery power icon displays near the title bar The icon contains up to 4 vertical bars to indicate the amount of power left in the batteries When the batteries run low the testing c...

Page 64: ...y cover on the bottom of the analyzer a Press down on the tab b Pull out the battery cover 5 Replace the batteries a Remove the current batteries b Place 6 new AA size batteries into the analyzer 6 Insert the battery cover 7 Turn the analyzer back onto its base 8 Insert the test table and table insert CAUTION Do not use batteries in the analyzer if you run a CLINITEK Status analyzer with a CLINITE...

Page 65: ...hen you power on the analyzer restart the test Error Messages Error messages display to help you when the CLINITEK Status analyzer detects an issue that needs your attention The type of error message depends on the importance of the problem and the mode in which you use the analyzer The error messages include the following types Errors that disable the analyzer Errors that require correction Advis...

Page 66: ... first advisory error message the analyzer displays the next advisory error message Results Alert If an error occurs during testing and the test cannot continue because of the error a message displays on the Results Alert screen The results alert error message provides details about the error and shows that the test was cancelled The analyzer pushes out the test table so that you can remove the ur...

Page 67: ... the instructions See Section 4 Maintenance Changing the Batteries page 63 Change the Power Save setting to extend the battery life For details see Section 7 System Configuration Changing the System Settings page 107 E02 Failure of calibration data Contact your local technical support provider or distributor E03 E04 E05 E06 E07 E08 E21 E22 E90 E91 E92 or E93 Failure of computer software Contact yo...

Page 68: ... power cord from the back of the analyzer and connect it back in Press the on off button to power on the analyzer 4 If the error remains with the test table in place contact your local technical support provider or distributor See Appendix B Support Information When to Contact Technical Support page 131 E12 Failure of LED An LED light source failed Contact your local technical support provider or ...

Page 69: ...y life For details see Section 7 System Configuration Changing the System Settings page 107 E24 No printer paper Replace the printer paper by using any of the following instructions On the screen select Error Report to view the instructions Lift the printer paper compartment cover to view the instructions inside See Section 1 Introduction Loading the Printer Paper page 14 E25 E64 or E65 Failure of...

Page 70: ... Note For ID band urinalysis strips skip step 1 1 Ensure that the strip type you selected in Instrument Set Up is the type you use see Section 7 System Configuration Changing the Urinalysis Test Settings page 112 2 Verify that you correctly placed the strip on the test table insert If you used the correct type of strip and you correctly placed the strip on the test table insert check the analyzer ...

Page 71: ...age 29 E57 Missing strip or cassette Repeat the test and ensure that you correctly position the strip or cassette on the test table see Section 2 Operations Performing a Urinalysis Strip Quick Test page 29 or Performing an hCG Cassette Quick Test page 35 E58 Misplaced strip 1 Repeat the test and ensure that you correctly position the strip on the test table see Section 2 Operations Performing a Ur...

Page 72: ...g a Urinalysis Strip Quick Test page 29 E61 Dry strip Repeat the test with a fresh strip and ensure that the strip has been in contact with the sample see Section 2 Operations Preparing a Urinalysis Strip Quick Test page 29 E62 Light Ingress Too much light is reflecting on the analyzer Move the analyzer to a location with lower lighting Contact your local technical support provider or distributor ...

Page 73: ...urs with a highly colored or visibly bloody or viscous sample collect a fresh sample and repeat the test If the error occurs with quality control testing consider using a different control solution product E69 Strip quality problem When the analyzer performed a quality check the strip quality failed The quality check detects whether the strip was compromised due to humidity exposure Also some comm...

Page 74: ...displays when the battery power level is low The power level decreases while the testing continues If the battery level falls too low to power the analyzer you cannot run a test until you replace the batteries Replace the batteries For instructions see Section 4 Maintenance Changing the Batteries page 63 No Printer Paper Displays on the Print Help button on the Select Ready screen indicating that ...

Page 75: ...hysically a cable broke or the connector platform stopped working Check the connectors and cables If the connectors physically connect the analyzer to the connector platform and the cables are not broken call your local technical support provider or distributor No Remote Connection Displays only if you run a CLINITEK Status analyzer with a CLINITEK Status connector Indicates that the wired Etherne...

Page 76: ...hese items help the technical support representative work on the issue as quickly as possible Error number Completed problem list see Problem List page 77 Description Action Display shows dashes Dashes in a field indicate where you disabled a an option Dashes also display when you exclude urinalysis tests for chemistries from the test results You can write the information on the blank lines in the...

Page 77: ...tor Clinitek Status Analyzer Problem List Serial Number _____________________________ Installation Date ___________________________ Software Version __________________________ YES NO 1 Have you reviewed the error messages on pages 67 73 2 Record any error messages that display ________________________________________ ________________________________________ ________________________________________...

Page 78: ...oassay cassette shown on the display the same as the product being used 9 Does the display or printout show the correct test names and expected results 10 Is the white calibration bar on the test table dirty scratched or damaged 11 Additional problem observations please describe _____________________________________________ _____________________________________________ ____________________________...

Page 79: ...utomatically sends the test results to a computer while you test the sample and when you recall results if configured and if connected Print all the test results or individual test results Delete the test results If you connect the analyzer to a computer through a serial port you can send the test results to the host computer You also can set up the analyzer to automatically transfer the test resu...

Page 80: ...e QC feature is available only with a CLINITEK Status connector For details see the CLINITEK Status Connect System Operator s Guide The Recall Options screen displays 3 Select Patient Tests default if necessary and select Next 4 Search for the results in either of the following ways or view all the results by skipping to step 5 To search by patient name or patient ID perform the following steps a ...

Page 81: ...s select Print All Any information you entered for a patient displays on the printout 8 Select Back Done to return to the Select Ready screen To view and print individual patient test results perform the following steps 1 Highlight the result you want to recall 2 Select Select to view the result details 3 Select Print to print the result 4 When you finish viewing the result select Done The Select ...

Page 82: ...ults to a computer perform the following steps 1 Enable the Allow results to be sent to PC option in Instrument Set Up 2 On the Select Ready screen select Recall Results The Recall Options screen displays 3 Select Recall Results The Recall Results Search Results screen displays with the stored patient results 4 Using the scroll arrows scroll down to highlight the patient record and then select Sel...

Page 83: ...y screen select Recall Results The Recall Options screen displays 2 Select Delete Records The system displays a confirmation message 3 Select Yes CAUTION Before you delete any test results be sure that the loss of the test results is acceptable If you did not send the test results to a host computer or printer Siemens recommends that you perform those tasks before you delete the results Keep in mi...

Page 84: ...84 CLINITEK Status Analyzer Operator s Guide File Management ...

Page 85: ...Settings You can view and print the system configuration settings as explained in Viewing and Printing the System Configuration Settings page 127 The following table contains the system configuration options with their default settings for English US Note For CLINITEK Status connector system configuration settings see the CLINITEK Status Connect System Operator s Guide Section 6 System Configurati...

Page 86: ... not set Patient ID Disabled Patient Name Disabled Plus System Disabled Power Save Disabled Printer Internal Automatic QC Strip QC test prompts Disabled Type of prompt Required QC confirmed by Instrument QC Strip Lock out No Tests per QC 2 Test Interval Days Hours 8 Days 1 Number of Shifts 3 QC Times 06 00 14 00 22 00 For details about the QC control level default settings print the system configu...

Page 87: ...nfiguration settings see Viewing and Printing the System Configuration Settings page 127 Results Format Units Selection Conventional Results Printout Custom information internal notes operator name patient name patient ID serial number urine color urine clarity Enabled Header Disabled Sample Appearance None Sample Interference Notes Enabled Serial Port Connectivity Enabled Baud rate 57600 Parity N...

Page 88: ...low Dark Yellow Amber Brown Red Orange Pink Green Blue Other Urine Colors Customized None Configuration Option Default Setting Bar code reader Disabled Connectivity Platform Disabled Network connection Serial connection QC Cassette Level 1 Positive 2 Negative QC Strip QC Test Prompts Disabled Type of Prompt Required QC Confirmed by Instrument QC Strip Lock Out No Tests per QC 2 Test Interval Days ...

Page 89: ...and Printing the System Configuration Settings page 127 Wireless connectivity Connectivity Disabled Security Disabled Authentication Open system IEEE 802 1X Disabled Pre shared Key Disabled WEP Key Index 1 WPA Encryption TKIP IP Configuration DHCP Gateway No Comms Protocol POCT1 For details about the gateway default settings print the system configuration settings see Viewing and Printing the Syst...

Page 90: ...characters you enter display as asterisks Select Enter The Choose Settings screen displays 2 Use the up and down arrows to scroll through the list and highlight a setting 3 Select Select 4 Make your changes to the settings 5 Select Done until the Select Ready screen displays Changing the Language Settings You can specify the language you want for your system The following languages are available E...

Page 91: ...he languages and highlight the language you want 4 Select Select A confirmation message displays 5 Select Yes 6 Select Done CAUTION If you change the language the system deletes all the test results in the current language If you want to continue using the same language select No The Choose Settings screen displays ...

Page 92: ... Disabled Disabled Disabled Last Operator button display Disabled Disabled Disabled Disabled Patient ID entry Disabled Disabled Disabled Disabled Patient Name entry Disabled Disabled Disabled Disabled Custom data entry Disabled Disabled Disabled Disabled Keyboard Priority Alpha Alpha Alpha Alpha Units selection Conven tional SI Conven tional SI Plus System Disabled Disabled Disabled Disabled Mark ...

Page 93: ...Date Format dd mm yyyy dd mm yyyy yyyy mm dd dd mm yyyy Time Format 12 hour 24 hour 24 hour 12 hour Operator Name entry Disabled Disabled Disabled Disabled Last Operator button display Disabled Disabled Disabled Disabled Patient ID entry Disabled Disabled Disabled Disabled Patient Name entry Disabled Disabled Disabled Disabled Custom data entry Disabled Disabled Disabled Disabled Keyboard Priority...

Page 94: ...word select the left arrow key Back on the alphabetic keyboard The Choose Settings screen displays Note Be sure to keep a record of the password so that you can access Instrument Set Up If you lose your password call your local technical support provider or distributor 4 Select Enter 5 Select Done To remove a password perform the following steps 1 On the Select Ready screen select Instrument Set U...

Page 95: ...ick Test When you run a Quick Test the system runs the test and assigns a sequential test number that displays when the results display or print Note You cannot enter patient and operator information with a Quick Test To select a Quick Test perform the following steps 1 On the Select Ready screen select Instrument Set Up 2 On the Choose Settings screen select Operator and Patient Information 3 Sel...

Page 96: ... Select Full Test 4 Select Next 5 Select Done Custom Set Up You can select any of the following custom settings Operator name Alphabetic or numeric keypad priority Patient name Patient ID Bar code reader Patient name or patient ID in the Results list Last operator s name displayed Sample appearance Custom field for frequently used information such as Physician Name To customize the patient operato...

Page 97: ...en you run a test Disabled default does not prompt you to enter an operator name when you run a test Keypad priority Numeric during data entry displays the numeric keyboard as the first keyboard Alphabetic default during data entry displays the alphabetic keyboard as the first keyboard Screen 2 of 5 Patient Name Enabled prompts you to enter a patient name when you run a test Disabled default does ...

Page 98: ... oldest test from the list You cannot recall a deleted test result Note If you disable Patient Name and Patient ID the system displays a sequential test number with the test results Bar code reader settings 1 Select Barcode Reader Settings 2 Enable or disable the bar code reader Enabled requires you to enter a patient name and patient ID only by bar code reader Disabled default allows you to enter...

Page 99: ...strip or cassette test Disabled default does not display the last operator name when the system prompts you to enter an operator name during a strip or cassette test Screen 4 of 5 Choose which to record during a strip test Color and Clarity displays and prints the urine sample color and clarity for a strip test Color only displays and prints the urine sample color for a strip test Clarity only dis...

Page 100: ...ne color Screen 5 of 5 Custom Field Enter Custom Field allows you to create a label for a custom field For example if you create a label PHYSICIAN the system displays the prompt Enter Patient Information PHYSICIAN Then you would enter the physician name Enabled displays the custom field when you run a test Disabled default does not display the custom field when you run a test To create a custom fi...

Page 101: ...stom Set Up Select Next 4 On the Custom Settings Operator 1 of 5 screen select Next 3 times 5 On the Custom Settings Sample Appearance 4 of 5 screen select Edit colors The Sample Appearance Select colors 1 of 3 screen displays Urine Color Option Description Screen 1 of 3 Light yellow Yellow Dark yellow Amber Brown Red By default all colors are selected Select a selected color to exclude it Select ...

Page 102: ...name Note A color name can have a maximum of 10 characters 3 Select Enter The Sample Appearance Select colors screen 3 of 3 displays If a custom color exists the Sample Appearance alert screen displays 4 Select an option Select Yes to edit the custom color and delete all the records Select No to return to the Sample Appearance Select Colors 3 of 3 screen To delete a custom color perform the follow...

Page 103: ...3 On the Set Date Time screen use the up and down arrows to adjust the date and time 4 Select AM or PM if you want the 12 hour time format 5 Select Set 6 Select Done To change the date and time format perform the following steps 1 On the Select Ready screen select Instrument Set Up 2 On the Choose Settings screen select Date and Time Settings 3 On the Set Date Time screen select Choose Format 4 On...

Page 104: ...ce to return to the Select Ready screen Changing the Instrument Settings The instrument settings control the way the system displays information and operates The instrument settings include the following options Results Format System Settings Display Contrast Connectivity Urinalysis Test Settings Authorized Operator Printer Settings QC Settings Software Update To change the instrument settings per...

Page 105: ...m Conventional SI Systéme International Nordic units Plus System Mark positive results with an asterisk Store the instrument serial number in the patient records To change the results format perform the following steps 1 On the Select Ready screen select Instrument Set Up 2 On the Choose Settings screen select Instrument Settings 3 On the Instrument Settings screen select Results Format The Choose...

Page 106: ...I units are available only in Chinese If you set the language to Chinese the Choose Format 1 of 2 screen does not display Plus System Enabled displays the test results in the Plus System Results that you record in the Plus System use plus symbols instead of clinical units such as mg dL Note For some languages the Normal System and the Plus System test results are the same as shown in Appendix D Sp...

Page 107: ... screen select Instrument Settings 3 On the Instrument Settings screen select System Settings Mark Positive Results Yes displays an asterisk next to the positive results on the screen a printout and when you transfer the data to a host computer For more information see Appendix D Specifications Tables of Results page 137 No default does not mark the positive results Store instrument serial number ...

Page 108: ...each test automatically after you complete the test Manual does not print the test results automatically Select Print on the Results screen to print the test results This option extends the battery life Off the test results do not print This option extends the battery life You might want to select the Off option when the printer runs out of printer paper while you send data to the LIS or host comp...

Page 109: ...es Power Save is always activated After the system remains idle for 5 minutes it powers down Disabled default deactivates Power Save mode if you power the system from an electrical outlet Screen 2 of 2 Sound Sound on default plays a range of audible tones when you select an area button or key on the screen Also a tone sounds if you have a problem performing a task Sounds range from a single beep t...

Page 110: ...p and down arrows to view each contrast setting 5 When you find the contrast setting you want select Select 6 Select Done twice to return to the Select Ready screen Changing the Connectivity Settings You can connect the analyzer to a PC or host computer through a serial port If you have a Status connector you can connect the analyzer to an LIS using a wired Ethernet or wireless network or send dat...

Page 111: ...or Stop Bits select 1 or 2 8 Select Done 4 times to return to the Select Ready screen Connectivity Option Description Screen 1 of 2 Connectivity Platform Enabled allows communication between the analyzer and the connector Disabled default prevents communication between the analyzer and the connector Allow results to be sent to PC Enabled default allows the analyzer to send the test results to a PC...

Page 112: ...nalysis Test screen select a urinalysis strip Note Some Siemens strips are not on the list of strips such as CLINITEK Microalbumin and Multistix PRO The system identifies them through the color ID band on the strip Other Siemens strips include a white ID band that identifies the strip type 5 Select Next 6 Select Done 3 times to return to the Select Ready screen Changing the Lot Number and Expirati...

Page 113: ...tion date before each test Disabled does not display a prompt to enter strip or cassette lot number and expiration date before each test 6 Select Done 3 times to return to the Select Ready screen Editing the Reported Chemistries By default the system reports all chemistries in the test results GLU BIL KET SG BLO pH PRO URO NIT LEU ALB and CRE You can include or exclude chemistries from the test re...

Page 114: ...eir name to perform those tasks You can add edit and delete authorized operators Note When you enable the Instrument Set Up password you restrict access to Instrument Set Up for only those operators who know the password If you enable the Authorized Operator setting and the Instrument Set Up password the operator name has priority over the Instrument Set Up password Enable or Disable Authorized Op...

Page 115: ...isplay in the list be sure to return to the Select Ready screen That way the system disables the Authorized Operator setting and you can continue to gain access to the system To add an operator perform the following steps 1 On the Select Ready screen select Instrument Set Up 2 On the Choose Settings screen select Instrument Settings 3 On the Instrument Settings screen select Authorized Operator 4 ...

Page 116: ...the following steps 1 On the Select Ready screen select Instrument Set Up 2 On the Choose Settings screen select Instrument Settings 3 On the Instrument Settings screen select Authorized Operator 4 On the Authorized Operator screen select View operators list 5 On the Authorized Operator Operators list screen scroll to and highlight the operator name you want to edit and select Select 6 On the Auth...

Page 117: ...uthorized operators View the operators list Authorized Operator Option Description Screen 1 of 2 Patient test Enabled default lets the operator run patient tests Disabled prevents the operator from running patient tests QC test Enabled lets the operator run QC tests Disabled prevents the operator from running QC tests Screen 2 of 2 Recall results Enabled lets the operator recall results Disabled p...

Page 118: ...e operator name 4 Select Done To delete an operator perform the following steps 1 On the Authorized Operator Operators list screen select an operator 2 Select Delete entry 3 Select Yes to confirm the deletion Note To add an operator see Add an Operator page 115 To print all operators perform the following steps Select Print The system prints only the first 100 operators and in alphabetical order N...

Page 119: ...results Visibly bloody urine may cause falsely elevated PRO results High SG may cause falsely lowered LEU results High pH may cause falsely elevated PRO results To set up sample interference notes perform the following steps 1 On the Select Ready screen select Instrument Set Up 2 On the Choose Settings screen select Instrument Settings 3 On the Instrument Settings screen select Sample Interference...

Page 120: ...et Up 2 On the Choose Settings screen select Instrument Settings 3 On the Instrument Settings screen select Printer Settings 4 On the Printer Settings Included in print out 1 of 4 screen select or clear any of the following options Operator Name Patient Name Serial Number Patient ID 5 Select Next On the Printer Settings Included in print out 2 of 4 screen select or clear any of the following optio...

Page 121: ...elect External printer Note If you select External printer sample interference notes print automatically To print to the internal printer select Internal printer default If you select Internal printer and want to print sample interference notes select Enabled for the Print notes on internal printer option To disable printing sample interference notes select Disabled 9 Select Done 3 times to return...

Page 122: ...ore Default Settings 4 On the Restore screen scroll up and down to view the default settings 5 Select Restore to return the system to the settings in the Restore list 6 Select Yes to confirm your decision Note Select No to maintain the current settings and return to the Restore screen 7 Select Exit Updating the Analyzer Software Periodically Siemens adds new features and makes improvements to the ...

Page 123: ...alyzer faces you d Lift the printer cover CAUTION Ensure you have printed or recorded the most recent patient results before you perform the software upgrade because the upgrade process deletes all patient records and all patient test results in the system For more information about recall results see Section 6 File Management CAUTION Do not use battery power when you upgrade the software If you d...

Page 124: ...The analyzer beeps repeatedly in a low tone for up to 90 seconds The System Test in progress screen displays briefly The test table extends The Software Update screen displays 5 Select Install Software A blank screen displays for up to 3 minutes during the following installation process The analyzer beeps repeatedly in a low tone for up to 75 seconds Next you hear 1 longer beep 1 Memory Card Slot ...

Page 125: ...ar the error message by continuing with the steps in the next section on how to complete the software upgrade Note The E27 message indicates that a significant change was made to the system database and occurs with a successful software upgrade from software Version 1 x To complete the software upgrade perform the following steps 1 Press the on off power button until the analyzer powers off The te...

Page 126: ...creen select Diagnostics 4 On the Select Diagnostics Test screen select a diagnostic test 5 Select Select 6 Read the onscreen instructions 7 Select Run Test 8 Select Done twice Viewing the System Information You can view the following system information Serial number Software version CAUTION Do not run the Check Cassette diagnostics on your own Run the Check Cassette diagnostic tests only when you...

Page 127: ... For more information see the CLINITEK Status Connect System Operator s Guide Section 6 System Configuration To view and print the system configuration settings perform the following steps 1 On the Select Ready screen select Instrument Set Up 2 On the Choose Settings screen select Instrument Settings 3 Select System Configuration The System Configuration screen displays with the current system con...

Page 128: ...128 CLINITEK Status Analyzer Operator s Guide System Configuration ...

Page 129: ...n involving infectious agents biological in nature such as the hepatitis B virus the human immunodeficiency virus and the tuberculosis bacterium These infectious agents may be present in human blood blood products and other body fluids Recognizing Sources of Contamination When you handle potentially infectious agents keep in mind the following major sources of contamination Hand to mouth contact H...

Page 130: ...e analyzer sample path or waste area with 10 v v bleach Do not eat drink smoke or apply cosmetics or contact lenses while in the laboratory Do not mouth pipette any liquid including water Do not place tools or any other items in your mouth Do not use the biohazard sink for personal cleaning such as rinsing coffee cups or washing hands References 1 Centers for Disease Control Update Universal preca...

Page 131: ...ervice contact your local technical support provider for assistance instructions repair or replacement of this instrument Legal Information To contact a legal representative for Siemens Healthcare Diagnostics in the European community contact the Siemens Authorized Representative When to Contact Technical Support Call for assistance if the following circumstances occur An error message continues t...

Page 132: ...re calling please complete the Problem List page 77 Make a photocopy of the list first This information helps your local technical support provider to identify the probable cause of the problem To order supplies or replacement parts or to obtain service contact your local technical support provider or visit www siemens com diagnostics ...

Page 133: ...ps for Urinalysis Chek Stix Combo Pak Control Strips for Urinalysis Chek Stix Positive Control Strips for Urinalysis Clinitest hCG Cassettes Thermal Printer Paper 5 rolls Label paper 5 rolls Optional Equipment CLINITEK Status connector Handheld bar code reader for use only with the CLINITEK Status connector Wireless adaptor for use only with the CLINITEK Status connector Replacement Parts Replacem...

Page 134: ...ilable for your CLINITEK Status analyzer Contact your local technical support representative to order any documentation Clinitek Status analyzer printed manual multiple languages available Clinitek Status analyzer multilingual CD Quick Reference Card printed manual multiple languages available LIS Interface Guide ...

Page 135: ...ions This appendix contains the analyzer specifications and tables of results Analyzer Specifications This appendix summarizes the design specifications for the CLINITEK Status analyzer and provides summary tables of test results from the CLIA waiver and the physician office studies ...

Page 136: ...8 to 30 C 64 to 86 F Ambient Operating Humidity Range 18 to 80 Relative Humidity non condensing Optimum Operating Temperature Range 22 to 26 C 72 to 79 F Optimum Operating Humidity Range 35 to 55 Relative Humidity non condensing Optimum ranges insure that the reagent results are optimized for performance For example at temperatures under 22 C 72 F urobilinogen and leukocyte results might decrease ...

Page 137: ...uction manual may cause harmful interference to radio communications Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense Safety Certifications For safety certifications information see the Declaration of Conformity DoC Contact your local technical support provider for the Do...

Page 138: ...for reagent strips The results shown in the shaded areas are marked as positives if you enabled Mark Positive Results in Instrument Set Up They are marked by asterisks when displayed and printed and when the CLINITEK Status analyzer transfers the data to a host computer Table D 1 English Units Conventional Reagent Strips Test Abbreviation Units Reported Results Normal System Plus System Glucose GL...

Page 139: ...tive 2 Trace 80 Trace 3 15 160 1 4 Specific Gravity SG 1 005 1 020 No Difference 1 010 1 025 1 015 1 030 Occult Blood BLO Negative Small Negative 1 Trace lysed Moderate Trace lysed 2 Trace intact Large Trace intact 3 pH pH 5 0 6 5 7 5 No Difference 5 5 7 0 8 0 6 0 7 5 8 5 Test Abbreviation Units Reported Results Normal System Plus System ...

Page 140: ...er reagent strips PRO mg dL Negative 100 Negative 2 Trace 300 Trace 3 250 1 Urobilinogen URO E U dL 0 2 4 0 No Difference 1 0 8 0 2 0 Nitrite NIT Negative Positive No Difference Leukocytes LEU Negative Moderate Negative 2 Trace Large Trace 3 Small 1 Albumin ALB mg L 10 80 No Difference 30 150 Test Abbreviation Units Reported Results Normal System Plus System ...

Page 141: ...mal 300 High Abnormal No Difference 30 300 Abnormal Albumin Creatinine CLINITEK Microalbumin 9 A C mg g Normal Dilute 30 Normal 30 300 Abnormal 300 No Difference High Abnormal Protein Creatinine Multistix PRO P C mg g Normal Dilute Normal 300 Abnormal 500 Abnormal No Difference 150 Abnormal Test Abbreviation Units Reported Results Normal System Plus System ...

Page 142: ...nits Conventional Cassette Protein Creatinine CLINITEK Microalbumin 9 P C mg g Normal Dilute Normal 3000 Abnormal No Difference 300 Abnormal 1500 Abnormal 5000 Abnormal Test Abbreviation Units Reported Results Normal System Plus System Human Chorionic Gonadotropin hCG hCG Negative hCG Positive No Difference Borderline hCG level Test fresh sample in 48 72 hours Test Abbreviation Units Reported Resu...

Page 143: ...s for reagent strips The results shown in the shaded areas are marked as positives if you enabled Mark Positive Results in Instrument Set Up They are marked by asterisks when displayed when printed and when the CLINITEK Status analyzer sends the data to a host computer Table D 3 English Units International SI Reagent Strips Test Abbreviation Units Reported Results Normal System Plus System Glucose...

Page 144: ...e 2 Trace 7 8 Trace 3 1 5 15 6 1 4 Specific Gravity SG 1 005 1 020 No Difference 1 010 1 025 1 015 1 030 Occult Blood BLD Ery µL Negative Ca 25 Negative 1 Trace lysed Ca 80 Trace lysed 2 Trace intact Ca 200 Trace intact 3 pH pH 5 0 6 5 8 0 No Difference 5 5 7 0 8 5 6 0 7 5 9 0 Test Abbreviation Units Reported Results Normal System Plus System ...

Page 145: ...er reagent strips PRO g L Negative 1 0 Negative 2 Trace 3 0 Trace 3 0 3 1 Urobilinogen UBG µmol L 3 2 66 No Difference 16 131 33 Nitrite NIT Negative Positive No Difference Leukocytes LEU Leu µL Negative Ca 125 Negative 2 Ca 15 Ca 500 Trace 3 Ca 70 1 Albumin ALB mg L 10 80 No Difference 30 150 Test Abbreviation Units Reported Results Normal System Plus System ...

Page 146: ... 33 9 High Abnormal No Difference 3 4 33 9 Abnormal Albumin Creatinine CLINITEK Microalbumin 9 A C mg mmol Normal Dilute 3 4 Normal Abnormal 33 9 High No Difference 3 4 33 9 Abnormal Protein Creatinine Multistix PRO P C mg mmol Normal Dilute Normal 33 9 Abnormal 56 6 Abnormal No Difference 17 0 Abnormal Test Abbreviation Units Reported Results Normal System Plus System ...

Page 147: ...rnational SI Cassette Protein Creatinine CLINITEK Microalbumin 9 P C mg mmol Normal Dilute Normal 339 Abnormal No Difference 33 9 Abnormal 170 Abnormal 566 Abnormal Test Abbreviation Reported Results Normal System Plus System Human Chorionic Gonadotropin hCG hCG Negative hCG Positive No Difference Borderline hCG level Test fresh sample in 48 72 hours Test Abbreviation Units Reported Results Normal...

Page 148: ...c units for reagent strips The results shown in the shaded areas are marked as positives if you enabled Mark Positive Results in Instrument Set Up They are marked by asterisks when displayed when printed and when the CLINITEK Status analyzer sends the data to a host computer Table D 5 English Nordic Units Nordic Plus System Reagent Strips Test Abbreviation Units Reported Results Normal System Plus...

Page 149: ...ne KET Negative 3 Negative 2 1 4 Trace 3 2 5 1 4 Specific Gravity SG 1 005 1 020 No Difference 1 010 1 025 1 015 1 030 Occult Blood BLD Negative 1 No Difference 2 Intact 3 pH pH 5 0 6 5 8 0 No Difference 5 5 7 0 8 5 6 0 7 5 9 0 Test Abbreviation Units Reported Results Normal System Plus System ...

Page 150: ...otein All other reagent strips PRO Negative 2 Negative 2 3 Trace 3 1 1 Urobilinogen UBG µmol L 3 2 66 No Difference 16 131 33 Nitrite NIT Negative Positive No Difference Leukocytes LEU Negative 3 Negative 2 1 4 Trace 3 2 1 Albumin ALB mg L 10 80 No Difference 30 150 Test Abbreviation Units Reported Results Normal System Plus System ...

Page 151: ... 33 9 High Abnormal No Difference 3 4 33 9 Abnormal Albumin Creatinine CLINITEK Microalbumin 9 A C mg mmol Normal Dilute 3 4 Normal 3 4 33 9 Abnormal 33 9 No Difference High Abnormal Protein Creatinine Multistix PRO P C mg mmol Normal Dilute Normal 33 9 Abnormal 56 6 Abnormal No Difference 17 0 Abnormal Test Abbreviation Units Reported Results Normal System Plus System ...

Page 152: ... Nordic Plus System Cassette Protein Creatinine CLINITEK Microalbumin 9 P C mg mmol Normal Dilute Normal 339 Abnormal No Difference 33 9 Abnormal 170 Abnormal 566 Abnormal Test Abbreviation Reported Results Normal System Plus System Human Chorionic Gonadotropin hCG hCG Negative hCG positive No Difference Borderline hCG level Test fresh sample in 48 72 hours Test Abbreviation Units Reported Results...

Page 153: ...bols This following table contains the symbols that appear on the exterior of the CLINITEK Status analyzer the power supply provided with the analyzer the carton in which the analyzer was delivered and the urinalysis strips and cassettes supplies that you use with the analyzer Symbol Description Direct current input supply Double insulated product or transformer may also identify class 2 equipment...

Page 154: ...handling electrostatic sensitive devices to avoid causing a hazard to the product Symbol Description Serial port This analyzer contains certain toxic or hazardous substances or elements The environmental protection use period for this analyzer is 50 years The analyzer can be used safely during its environmental protection use period The analyzer should be recycled immediately after its environment...

Page 155: ...nce with applicable local requirements Printed on recycled materials Indicates compliance with the RESY packaging standards Do not reuse a reagent Keep this way up Fragile handle with care Keep dry Keep away from sunlight and heat VDE Testing and Certification Institute Germany Manufacturer s mark FWHK and manufacturing location Hong Kong Manufacturer s mark FWGB and manufacturing location Gerateb...

Page 156: ... transformer at a specific temperature The operation temperature is stated below Ingress protection rating Protected against the entry of solid objects 1 mm but no protection from liquids Risk of electric shock Symbol Name Description Instrument Set Up Allows you to set up the analyzer to suit your needs Strip Test Runs a test with a urinalysis strip such as Multistix 10SG urinalysis test and disp...

Page 157: ...ry powered analyzer Low Battery Power Displays fewer than three bars indicating the battery power level of a a battery powered analyzer is low Paper Out Displays when you need to replace the printer paper or label roll Connector Indicates that the analyzer is connected to the CLINITEK Status connector No Connector Displays only if you run a CLINITEK Status analyzer with a CLINITEK Status connector...

Page 158: ...r is connected to the CLINITEK Status connector Connectivity is enabled and the system is connected to the LIS No Connectivity Displays only if you run a CLINITEK Status analyzer with a CLINITEK Status connector Indicates that the CLINITEK Status system is not connected to the wired Ethernet or wireless connection between the analyzer and the server on a remote computer Symbol Name Description ...

Page 159: ...ITEK Status analyzer The CLINITEK Status analyzer with increased memory and additional features CLINITEK Status Connect system The CLINITEK Status analyzer attached to the CLINITEK Status connector connector The CLINITEK Status connector platform where you can attach the CLINITEK Status analyzer display The LCD that displays the software user interface Ethernet port The port where a network Ethern...

Page 160: ...nd off serial connector An RS232 connection used to transfer data between the analyzer and a PC test table The plastic case that holds the test table insert test table insert The plastic case that holds either the cassette or urinalysis strip for testing touch screen The LCD display that lets the operator select controls on the screen USB port The ports where USB cables are inserted urinalysis str...

Page 161: ...nsure accurate test results cancel To end a sequence or anoperation comment A notation the operator enters for a QC test result configuration System hardware and software settings that adjust or configure some aspect of the analyzer conventional unit Unit of measurement for test results control Objects that display on the software UI that the operator can manipulate Buttons boxes and optionbuttons...

Page 162: ...r An event that prevents the analyzer from operating as expected error code A number displayed by the analyzer to communicate the occurrence of an error to the operator export To copy setup data from the analyzer to a removable data storage device Full Test A strip or cassette test where the operator is prompted to enter patient and operator information help Information presented to the operator t...

Page 163: ... A software UI button control that when selected brings the operator to a different software UI screen parity A serial communication setting that verifies whether the data has been transmitted accurately Plus System Provides plus symbols for a result The more plus symbols the higher the result For example 2 represents two plus symbols and 3 represents three plus symbols power supply Electronic com...

Page 164: ... analyzer software UI contains screens prompts messages and other operating information screen title A text label that typically displays in the upper left corner of a screen which serves as a label for that screen Select Ready screen The software UI screen that displays when the system completes the startup process All software UI navigation begins from the Select Ready screen settings The areas ...

Page 165: ...ice during data transmission test result Measured reportable values displayed to the operator at the end of a test sequence test sequence A series of software UI screens that guides the operator through the tasks required to perform a test on a sample Title bar The area along the top of software UI screens where the location icon and title display troubleshooting Determining the cause of a system ...

Page 166: ...Information System HL7 Health Level 7 protocol IP Internet Protocol KET Ketone LAN Local Area Network LEU Leukocyte LIS Laboratory Information System NIST National Institute of Standards and Technology NIT Nitrite pH Hydrogen ion concentration PC Personal Computer POCT Point of Care Testing protocol PRO Protein QC Quality Control SG Specific Gravity SI Systéme International SN Serial Number UI Use...

Page 167: ...enabling 114 printing 118 setup 114 authorized operators list deleting 118 editing 118 viewing 118 B bar code reader default setting 85 88 error 70 handheld 19 ordering 133 settings 98 batteries changing 63 inserting 12 size 64 biohazard 129 bleach strength 61 C calibration 51 79 calibration bar cleaning 51 57 59 NIST 51 calibration overview 51 cassette check diagnostics 126 Chek Stix 133 chemistr...

Page 168: ...18 icons 156 E electrical requirements 136 electromagnetic compatibility EMC 137 entering information 27 environmental specifications 136 equipment optional 133 error messages 65 Ethernet connection 14 20 110 F Full Test hCG cassette 44 49 settings lot expiration date 112 lot number 112 urinalysis strip 38 44 G glossary acronyms 165 hardware terms 159 software terms 160 H hardware components 18 gl...

Page 169: ...tem units 148 units settings 105 numeric keyboard 27 O operations 29 operators adding 115 disabling 114 enabling 114 setup 114 operators list deleting 118 editing 118 printing 118 viewing 118 option button 24 optional equipment 133 P packaging symbols 153 parts replacement 133 password setup 94 Plus System 105 positive results marking 105 power batteries 20 cord 11 electrical 20 on and off 16 save...

Page 170: ...ering information 27 option 24 overview 18 select ready 21 title bar 21 touch 21 selection area 21 24 sending to computer all results 81 invidividual results 82 serial connection 111 number 105 126 port 11 settings analyzer 85 88 authorized operators 114 changing 90 chemistries 113 Clinitek Status connector 85 88 connectivity 110 custom setup 96 date 103 default 85 display contrast 110 instrument ...

Page 171: ...tings 107 T technical support 75 76 77 94 132 test sequence number 104 test table cleaning 57 disinfecting 60 inserting 12 overview 19 test table insert disinfecting 60 hCG cassette 13 inserting 12 urinalysis strip 13 testing controls 54 Full Test hCG cassette 44 urinalysis strip 38 Quick Test hCG cassette 35 urinalysis strip 29 Theracide 61 thermal printer 20 time settings 103 title bar 21 touch ...

Page 172: ...s Guide Full Test 38 44 quality control 54 Quick Test 29 34 urinalysis test settings 112 urine clarity setup 100 color customizing 101 editing 101 setup 100 Uristix 9 19 30 40 W water quality control 54 wired network 89 wireless network 89 ...

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